This study aims to analyze the effects of 4 weeks of low-intensity exercise with and without blood flow restriction (BFR) on pain, fear of movement, catastrophizing about pain, strength, and disability in a population with rotator cuff-related shoulder pain. There are two modalities corresponding to the same exercises under different blood flow restriction conditions: 1) 3 low-intensity exercises (30% 1RM) with BFR (50% AOP); 2) 3 low-intensity exercises (30% 1RM) without BFR. Participants will be randomly assigned to one of two groups and will undergo a 4-week intervention. The variables of interest will be assessed in each group for subsequent analysis and comparison.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
Three exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 30% RM and a 50% of arterial occlusion pressure. 30" rest between sets, 2' rest between exercises.
Three exercises: external rotation at 0°, internal rotation at 0° and elevation in the scapular plane. 4 sets (30, 15, 15, reps to fatigue) with a intensity of 30% RM and a without flow restriction application (cuff applied without pressure). 30" rest between sets, 2' rest between exercises.
Pain intensity during movement (Visual Analogue Scale, 0-10)
Pain intensity perceived on a Visual Analogue Scale during movement (flexion and abduction movement without load), being 0 no pain and 10 the worst pain imaginable.
Time frame: Baseline, 2 weeks, and 4 weeks.
Pain intensity at rest (Visual Analogue Scale, 0-10)
Pain intensity perceived on a Visual Analogue Scale, at rest, being 0 no pain and 10 the worst pain imaginable.
Time frame: Baseline, 2 weeks, and 4 weeks.
Pressure pain threshold
Pressure pain threshold measured in the middle deltoid (peripheral sensitivity) and tibialis anterior (central sensitivity), using an algometer.
Time frame: Before the session, immediately after, and 1 hour post-intervention
Kinesiophobia
Assessment of fear of movement or reinjury, assessed via the self-administered Tampa Scale of Kinesiophobia questionnaire.
Time frame: Baseline, 2 weeks, and 4 weeks.
Occurrence of adverse effects
Occurrence of adverse effects (e.g., pain, delayed onset muscle soreness, sudden weakness of the trained limb, redness or swelling of the trained limb, etc.) by self-report.
Time frame: Immediately after the intervention, 1 hour, 6 hours, 24 hours.
Pain Catastrophizing
Assessment of pain catastrophizing, measured using the self-report Pain Catastrophizing Scale (PCS), which evaluates exaggerated negative mental responses to actual or anticipated pain. The final score ranges from 0 to 52, with higher scores reflecting higher levels of catastrophizing.
Time frame: Baseline, 2 weeks, and 4 weeks.
Pain and Disability
Assessment of pain and disability, measured using the self-report Shoulder Pain and Disability Index (SPADI). The score ranges from 0 to 100. A score of 0 indicates best, 100 indicates worst. A higher score shows more disabillity.
Time frame: Baseline, 2 weeks, and 4 weeks.
Shoulder Disability
Assessment of shoulder disability, measured using the self-report Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH). The final score ranges from 0 (no disability) to 100 (severe/maximal disability), calculated from patient-rated difficulty on a 5-point scale for 30 items, with higher scores indicating greater impairment in arm, shoulder, and hand function.
Time frame: Baseline, 2 weeks, and 4 weeks.
Muscle Strength
Assessment of supraspinatus and internal and external rotator muscle strength, measured using a strap-secured handheld dynamometer.
Time frame: Baseline, 2 weeks, and 4 weeks.
Satisfaction with methodology
Assessment of participant satisfaction with the methodology used, measured at the end of the program using a 5-point scale: very satisfied (5), satisfied (4), neutral (3), dissatisfied (2), very dissatisfied (1).
Time frame: 4 weeks.
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